4.5 Statistical vs Clinical Significance

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Questions and Answers

Which of the following statements provides the most accurate description of statistical significance?

  • The probability that the observed effect occurred due to chance alone. (correct)
  • The practical importance of the research results in real-world applications.
  • The likelihood that a treatment will be effective, based on predetermined criteria.
  • The extent to which a treatment affects patients' daily lives.

In which scenario might a study with a large sample size yield statistically significant results despite minimal real-world impact?

  • When the results definitively indicate a cause-and-effect relationship.
  • When the genuine variance between treatment groups is negligible. (correct)
  • When the observed effect is readily apparent in clinical practice.
  • When the treatment groups demonstrate clear clinical improvement.

How is clinical significance best characterized?

  • The likelihood of rejecting the null hypothesis if it is false.
  • The extent to which research results are broadly applicable.
  • The probability of obtaining a p-value less than 0.05.
  • A treatment's minimal effect needed to be considered beneficial. (correct)

A clinical trial demonstrates a statistically significant reduction in pain scores (p < 0.05) with a new medication compared to placebo; however, the average reduction is only 0.5 points on a 10-point scale. What does this indicate?

<p>It is statistically significant, but the effect is small, so it lacks clinical significance. (D)</p>
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According to the sources, what is the most appropriate course of action if a study's results fail to achieve statistical significance but show a potential clinical benefit?

<p>Consider if chance or sample size affected results and conduct more research. (D)</p>
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Which statement represents a common misunderstanding of p-values?

<p>The study results are reliable if the p-value is less than 0.05. (B)</p>
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What primary information does a p-value provide?

<p>The degree of evidence against the null hypothesis. (D)</p>
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Consider a study reporting a 95% confidence interval for blood pressure reduction with a new drug versus placebo (0.1 mmHg to 0.5 mmHg, p-value=0.03). Clinicians deem a 5 mmHg change clinically meaningful. How should this study's findings be interpreted?

<p>The results are statistically significant, but may not be clinically significant. (D)</p>
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According to the sources, when should a clinically significant level be determined?

<p>Before conducting the study. (C)</p>
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When a study achieves both statistical and clinical significance, what can be inferred about the results?

<p>The results are more likely to offer clinical benefit. (C)</p>
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A new drug significantly reduces blood pressure (p < 0.05). However, dietary changes show a more substantial impact but aren't statistically significant (p = 0.08). Considering both statistical and clinical significance, what should clinicians prioritize?

<p>Explore dietary changes despite the p-value. (B)</p>
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A researcher observes a strong correlation between exercise frequency and mental well-being (p < 0.01). However, the study participants were highly motivated volunteers. What should be considered when applying these findings to the general population?

<p>The sample population may not translate into general well being. (C)</p>
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A new therapy shows a 15% improvement (p < 0.05), but it requires 6 hours of weekly commitment for six months. Existing therapy shows 10% improvement with 1 hour of weekly commitment for six months. How should this be evaluated?

<p>Consider patient burden or the degree of effort. (D)</p>
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A large-scale study on a treatment for a rare disease shows a small but statistically significant benefit (p < 0.05). However, the treatment has severe side effects. What is the most relevant consideration when determining if the treatment should be widely adopted?

<p>Clinicians should carefully consider the potential harm. (C)</p>
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A study finds that a new teaching method improves test scores by 2% (p < 0.05) across a large student population. However, implementing the new method requires extensive teacher training and new resources. What is the most important factor to consider before implementing this method?

<p>The costs outweigh the benefits. (B)</p>
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What is a key difference between statistical significance and clinical significance?

<p>Statistical significance assesses result validity, while clinical significance determines practical impact. (D)</p>
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When designing a clinical study, why is it important to establish a clinically meaningful difference before data collection?

<p>To set a benchmark for evaluating the real-world impact of a treatment. (D)</p>
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In healthcare, if a new treatment strategy is highly effective (substantial clinical significance) but lacks funding for a large study (limited statistical significance), what further steps might be taken?

<p>Conduct studies with smaller populations. (B)</p>
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Why might healthcare regulators prioritize clinical significance over statistical significance?

<p>Clinical significance provides insights into treatment effects. (C)</p>
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Which scenario demonstrates a situation where clinical experience can help enhance the understanding of statistical significance?

<p>When statistical anomalies appear in datasets. (B)</p>
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Which of the following best describes statistical significance?

<p>The reliability of the study results, indicating whether the observed effect is likely due to chance. (C)</p>
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A study with a very large sample size might show a statistically significant result even if the actual difference between treatment groups is:

<p>Very small and potentially not clinically relevant. (B)</p>
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Clinical significance is best defined as:

<p>The smallest treatment effect that would be considered beneficial or harmful in clinical practice. (A)</p>
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A clinical trial for a new pain medication shows a statistically significant reduction in pain scores (p < 0.05) compared to a placebo. However, the average reduction in pain on a 10-point scale is only 0.5 points. According to the sources, this result is:

<p>Statistically significant but may not be clinically significant because the magnitude of the effect is small. (A)</p>
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If a study does not achieve statistical significance but the observed effect shows a potential clinical benefit, the sources suggest:

<p>That it could be due to chance or a small sample size (underpowered study), and further research might be needed. (D)</p>
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Which of the following is a misconception regarding p-values according to the sources?

<p>The p-value is the probability that the null hypothesis (i.e., no effect) is true. (C)</p>
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The p-value primarily indicates:

<p>The strength of the evidence against the null hypothesis. (D)</p>
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A study reports a 95% confidence interval for the difference in blood pressure between a new drug and a placebo as (0.1 mmHg to 0.5 mmHg), with a p-value of 0.03. While statistically significant, clinicians determine that a change of at least 5 mmHg is needed to be clinically meaningful. This study's findings are:

<p>Statistically significant but not clinically significant. (D)</p>
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According to the sources, a clinically significant level should ideally be:

<p>Determined before conducting the study. (B)</p>
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When a study achieves both statistical and clinical significance, the results are:

<p>More likely to be valuable findings with clinically meaningful results. (C)</p>
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Flashcards

Statistical Significance

The reliability of study results; indicates if the observed effect is likely due to chance.

Clinical Significance

The smallest treatment effect considered beneficial or harmful in clinical practice.

Large Sample Size Impact

Even a very slight difference between treatment groups may be statistically significant with a large sample.

P-Value

The p-value indicates the strength of evidence against the null hypothesis.

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P-Value Misconception

A misconception is that a p-value < 0.05 indicates study reliability.

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Clinically Significant Level

Determined before the study to ensure objectivity of the study.

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Statistical and Clinical Significance

These are more valuable findings with clinically meaningful results.

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Non-Significant Study

The study may need further research due to the chance of a small sample size.

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Generalizability

How much the study results can be applied to a larger group.

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Pain Medication Trial

A statistically significant reduction in pain scores may not be clinically significant if reduction is small.

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Study Notes

  • Statistical significance is best described as the reliability of study results, indicating whether the observed effect is likely due to chance.
  • A study with a very large sample size might show a statistically significant result even if the actual difference between treatment groups is very small and potentially not clinically relevant.
  • Clinical significance is best defined as the smallest treatment effect that would be considered beneficial or harmful in clinical practice.
  • A clinical trial for a new pain medication showing a statistically significant reduction in pain scores (p < 0.05) compared to a placebo, but the average reduction is only 0.5 points on a 10-point scale, is statistically significant but may not be clinically significant because the magnitude of the effect is small.
  • If a study does not achieve statistical significance but the observed effect shows a potential clinical benefit, it could be due to chance or a small sample size (underpowered study), and further research might be needed.
  • A misconception regarding p-values is that a p-value less than 0.05 indicates the reliability of the study results.
  • The p-value primarily indicates the strength of the evidence against the null hypothesis.
  • A study reporting a 95% confidence interval for the difference in blood pressure between a new drug and a placebo as (0.1 mmHg to 0.5 mmHg), with a p-value of 0.03, where clinicians determine that a change of at least 5 mmHg is needed to be clinically meaningful, is statistically significant but not clinically significant.
  • A clinically significant level should ideally be determined before conducting the study.
  • When a study achieves both statistical and clinical significance, the results are more likely to be valuable findings with clinically meaningful results.

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